Peter MacCallum Cancer Centre welcomes the Therapeutic Goods Administration (TGA) announcement that Novartis Kymriah® (tisagenlecleucel, formerly CTL019) has been approved for treating two aggressive blood cancers.
The TGA’s considerations were based on the review of the two global registration CAR-T clinical trials, JULIET and ELIANA, which included patients from Australia. In these trials, Kymriah delivered complete and durable response rates for some patients who otherwise had little chance of remission.
Kymriah® is approved for the treatment of relapsed or refractory patients with paediatric B-cell acute lymphoblastic leukaemia (ALL) and adult diffuse large B-cell lymphoma (DLBCL).
The TGA’s approval is a major milestone for Kymriah in Australia, and each step made towards future availability of this treatment for patients, is welcome.
“This CD19 CAR-T may change the treatment paradigm for relapsed diffuse large B-cell lymphoma and relapsed acute lymphoblastic leukaemia,” said Dr Michael Dickinson, Clinical Haematology.
When funding becomes available, Peter Mac is excited to be one of the first treatment sties in Australia.